On December 6, 2023 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported the presentation of analytical and clinical validation data on a novel prognostic test in early-stage lung cancer, generated through collaboration with the Samsung Medical Centre and AstraZeneca (LSE/STO/Nasdaq: AZN) (Press release, Grail, DEC 6, 2023, View Source [SID1234638208]). The results of the studies demonstrate sensitive and specific detection of circulating tumor DNA (ctDNA) for Lung Adenocarcinoma (LUAD) at a clinically meaningful threshold for disease prognostication. This is a novel tissue-free diagnostic that has the potential to identify high-risk patients prior to surgery and/or treatment. The findings were presented in poster sessions at the North America Conference on Lung Cancer 2023 in Chicago, held Dec. 1-3, 2023.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"These results are an important step in establishing oncology capabilities for GRAIL’s Methylation Platform for important cancer-specific applications beyond early cancer detection," said Jeffrey Venstrom, MD, Chief Medical Officer at GRAIL. "These studies demonstrate that a new tissue-free methylated ctDNA assessment in Stage I lung cancer can potentially identify patients at higher risk for recurrence."
The clinical validation studies analyzed pre-surgical plasma samples from 602 patients with EGFR/ALK wild-type clinical Stage I NSCLC (staging determined by TNMv8). A GRAIL assay was used to measure ctDNA detection with a prespecified threshold in a prospectively defined retrospective study. The presence of ctDNA correlated with an inferior two-year recurrence-free survival (HR 3.8 [95%CI 2.3–6.4], P<0.001 comparing ctDNA+ versus ctDNA-). ctDNA positivity in clinical stage I LUAD was associated with higher rates of mediastinal nodal upstaging at resection, PD-L1 positivity, and grade 3 histology.
In addition, analytical studies demonstrate analytical specificity of 96.9% (as determined in healthy donors), 100% accuracy to detect signal at low ctDNA input (2ng) and a robust LoD95 of 44 ppm tumor methylated fraction (TMeF: a measure of ctDNA abundance).
In 2022, GRAIL announced a broad strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca’s therapies.
In January 2023, GRAIL announced the availability of its state-of-the-art research use only (RUO) methylation solution which is being leveraged by pharmaceutical companies for custom oncology applications.